NEWS HIGHLIGHTS
Published Studies Related to Focalin (Dexmethylphenidate)
Dose effects and comparative effectiveness of extended release dexmethylphenidate
and mixed amphetamine salts. [2011]
specific impairments, and common adverse events associated with stimulants... CONCLUSIONS: Dose level, rather than stimulant class, was strongly related to
Efficacy of dexmethylphenidate for the treatment of fatigue after cancer chemotherapy: a randomized clinical trial. [2009.11]
Cancer and its treatment can induce subjective and objective evidence of diminished functional capacity encompassing physical fatigue and cognitive impairment. Dexmethylphenidate (D-MPH; the D-isomer of methylphenidate) was evaluated for treatment of chemotherapy-related fatigue and cognitive impairment...
Long-term effectiveness and safety of dexmethylphenidate extended-release capsules in adult ADHD. [2009.03]
CONCLUSION: Once-daily d-MPH-ER 20 to 40 mg is safe and effective for long-term treatment of adult ADHD.
Double-blind, randomized trial of dexmethylphenidate hydrochloride for the treatment of sarcoidosis-associated fatigue. [2008.05]
BACKGROUND: Fatigue is a common complaint in patients with sarcoidosis. We studied the effectiveness of dexmethylphenidate hydrochloride (d-MPH) in treating sarcoidosis-associated fatigue... CONCLUSIONS: Treatment with d-MPH was associated with a significant improvement in sarcoidosis-associated fatigue. TRIAL REGISTRATION: Clinicaltrials.gov Identifier: NCT00361387.
Double-blind, randomized trial of dexmethylphenidate hydrochloride for the treatment of Sarcoidosis Associated Fatigue. [2008.02.08]
Background Fatigue is a common complaint in sarcoidosis... Conclusions Treatment with d-MPH was associated with a significant improvement in sarcoidosis associated fatigue.
Clinical Trials Related to Focalin (Dexmethylphenidate)
Study of Dopamine Transporter Receptor Occupancy With Long-Acting Dex-Methylphenidate [Active, not recruiting]
The objectives of this study are to document the pharmacokinetics of the adequacy of DAT
receptor occupancy d-MPH formulation in three doses (20 mg, 30 mg, and 40 mg) using PET
scanning with C-11 Altropane as the ligand across a range of times. It has been estimated
that MPH is effective when the average CNS DAT occupancy is 50% or greater. Focalin XR has
been shown to be clinically effective in an analog classroom as early as 1 hour and as late
as 12 hours. Therefore, it is hypothesized that the average DAT occupancy will be adequate
(50% or greater) at time periods corresponding to the times of clinical efficacy.
The first objective is to examine the onset of action by testing whether average DAT
occupancy will be adequate (50% or greater) at 1 hour after dosing for each dose tested (20
mg, 30 mg, 40 mg).
The second objective is to test the adequacy of average DAT occupancy in a range of later
times for each dose. The times chosen (8, 10 and 12 hours) correspond to times Focalin XR has
been shown to be clinically effective in an analogue classroom study. A range of times have
been chosen since, while effective at 12 hours, the degree of clinical effectiveness
decreased with later time periods. The adequacy of DAT occupancy across this range of time
periods will provide important details on the in vivo molecular action of the medicine at
periods of critical clinical activity.
The third exploratory objective is to examine a time period later then those previously
tested with the highest dose. Since the clinical effectiveness of Focalin XR has not been
tested out to 14 hours, it is unknown whether it is effective at 14 hours. If Focalin XR were
to be effective at 14 hours it would be more likely at the highest dose.
D-MPH in the Treatment of Fatigue and Neurobehavioral Function Related to Chemotherapy in Adult Cancer Patients [Completed]
Efficacy, Tolerability and Safety of Dexmethylphenidate HCl Extended-Release Capsules in Children With Attention-Deficit/Hyperactivity Disorder [Completed]
The purpose of this study is to determine which dosages of dexmethylphenidate HCl
extended-release capsules may represent effective treatment for ADHD in children 6-12 years
of age.
Efficacy and Safety of Dex-Methylphenidate Extended Release 20 mg Versus Placebo in Children (6-12 Years) With Attention-Deficit/Hyperactivity Disorder (ADHD) in a Laboratory Classroom Setting [Completed]
This study will confirm the efficacy of dex-methylphenidate extended release 20 mg versus
placebo during an 8-hour laboratory classroom day.
Safety and Efficacy Study of Dexmethylphenidate in Children With ADHD [Completed]
The purpose of this study is to compare the safety and efficacy of two doses of
dexmethylphenidate to two doses of an approved, long-acting, marketed medication for ADHD
(MPH) and placebo in children ages 6-12 diagnosed with ADHD.
Reports of Suspected Focalin (Dexmethylphenidate) Side Effects
Weight Decreased (4),
Insomnia (4),
Product Substitution Issue (2),
Wrong Technique in Drug Usage Process (2),
Drug Ineffective (2),
OFF Label USE (2),
Autism (2),
TIC (2),
Product Quality Issue (2),
Drug Prescribing Error (2), more >>
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